Quality & Compliance Manager
Salary DOE: €50,000 – €60,000 + 10% Bonus + Full Blue-Chip Company Benefits
Location: Kundl, Austria with travel (approx. 20% within the DACH region)
Do you currently hold the title and responsibility of Senior QA Specialist, QA Manager, Senior Quality Manager, Head of Quality or similar?
Do you have experience of managing dynamic and diverse Quality & Compliance Teams?
Do you specialize in the Life Sciences, Biotech, Pharma, Laboratory Services or related field?
Are you tenacious, passionate, ambitious and results driven?
If you answered yes to the above, then this may be the ideal role for you…
The Requirements of the Quality & Compliance Manager:
- To be considered for the Quality & Compliance Manager role you must have a minimum of 5 years’ relevant experience working in a Quality Manager level role within the Pharmaceutical sector
- The ideal candidate will already have proven people management experience
- Ideally you will have experience working with organisations such as: Astra Zeneca Novartis, Bayer, Eli Lilly, Pfizer, Roche, GSK or a similar Pharmaceutical company
- Educated to bachelor’s degree in Biology, Microbiology, Chemistry, or Engineering; or equivalent related work experience
- Quality auditing experience is preferable
- FDA, ISO, or similar quality assurance audit related certification preferred
- Specialised training or certification in quality assurance audits, preferably FDA or ISO related preferred. Must have appropriate license and/or certification where required by law. Green or Black Belt Six Sigma Certification is preferable
- Experience with Desktop publishing, Microsoft Office Suite and Online Help. Previous experience with SAP, Trackwise, Regulus, and/or CMMS systems
- Well versed with Quality and Compliance management systems within Life Science Environment(s)
- You must have experience working in a compliance led and highly regulated industry
- You must have flexibility to travel to client sites across the DACH region and across Europe when required
- This is a customer facing and commercially focused sourcing position, the successful candidate must be able to positively influence and work with senior level stakeholders
- Excellent interpersonal, writing, editing, analytical and organisational skills
The role of the Quality & Compliance Manager:
- The Quality & Compliance Manager will manage the day-to-day Quality and Compliance Team operations at one or more account sites
- Monitors operations at each site and determines compliance status with regards to local and global regulatory standards as well as client specific requirements as defined in the master service agreement (MSA) or Quality Agreement
- Delivers and implements the agreed compliance program and/or the client’s compliance program
- Attends Quality Forum monthly meetings to provide in-depth explanations for monthly reports and department metrics
- Leads and participates in continuous improvement
- Interfaces, partners, and interacts with key functional areas and leadership teams
- Appropriately communicates quality and compliance initiatives and/or issues across the functional areas impacted
- Responsible for reporting Compliance (among other quality and business metrics) status to the client during review meetings
- Appropriately escalates and notifies the client of all quality and compliance issues
- Responsible for the inspection readiness program for the site. Inspection readiness may include periodic self-inspections, or any external agency inspections like the FDA
- Lead audits as well as serve as the primary quality representative during external agency or client audits
- Accountable to the client and/or agency for audit observations and the associated corrective measures
- Responsible for the vendor management program for the site
- Has the responsibility to ensure all GxP service providers are qualified per the regulated vendor qualification process (as well as any client directed qualification program)
- Accountable for approving all necessary quality agreements with third party service providers and ensuring the ongoing oversight of those vendors is executed
- Responsible for the training and qualification program for employees. Ensures that all employees are qualified for the role they perform
- Trains account personnel on the use of elements within the Quality Management System
- Ensures the QA staff are qualified and delivering on the objectives of the QMS, annual quality plan, and the quality agreement with the client
- Oversees the execution (may be required to participate) and tracks the success of quality of service initiatives on the account for non-regulated services
- Authors and negotiates terms of Quality Agreements with clients and vendors
- Investigates deviations/events, issues and manages Corrective/Preventative Actions
- Operating in multiple countries on a global scale my client is an industry leading 360-degree laboratory services provided for major multinationals in the Pharmaceutical & Life Sciences sector
- Key examples of these services include: Sourcing & Multi-vender management, Data Advisory, Programme Management and Innovation & Customer Engagement
For more information about the role or to apply send your CV now to email@example.com or call Oliver Gill today on +44 (0) 113 243 3499.
You must have the right to work in the EU.
Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone would be good for Quality & Compliance Manager role, email your nominated candidate’s name and contact details in confidence via email too, and we’ll ensure you receive £100.00 (o/e) of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.